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Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation (imATFIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584126
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
County Clinical Emergency Hospital Cluj-Napoca

Tracking Information
First Submitted Date June 19, 2018
First Posted Date July 12, 2018
Last Update Posted Date September 11, 2020
Actual Study Start Date April 25, 2017
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2018)		 Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation. [ Time Frame: 2016-2020 ]
A. Percentage of patients with left atrial fibrosis assessed by MRI among those with persistent atrial fibrillation. B. Correlation of the left atrial fibrosis localization and amount with persistent atrial fibrillation severity.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 10, 2018)		 Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers. [ Time Frame: 2016-2020 ]
A. Correlation of left atrial fibrosis with left atrial dimensions in patients and healthy volunteers. B. Correlation of left atrial fibrosis with blood bio-marker levels and echocardiography parameters in patients and healthy volunteers.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation
Official Title Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB
Brief Summary The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent atrial fibrillation (AF). The result of the study is a diagnostic method which aids the medical work-up of patients suffering from this disease.
Detailed Description Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity and mortality in humans. Histopathological studies of persistent AF have reported extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation. The degree of the fibrosis might have a significant impact on wave propagation during AF. The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent AF. The obtained clinical parameters of patients and controls (electrocardiography, ecocardiography and MR imaging data) will be correlated with known markers in order to identify novel markers for AF diagnosis.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Probability Sample
Study Population Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).
Condition Atrial Fibrillation
Intervention Diagnostic Test: Electrocardiography, ecocardiography and MRI.
AF patients and healthy adult volunteers will be examined by the study physicians and included in the study according to the inclusion criteria. After a general examination, an electrocardiography, an ecocardiography and an MRI will be performed on the AF-affected and healthy hearts, respectively.
Study Groups/Cohorts
  • Patients with AF
    Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI.
    Intervention: Diagnostic Test: Electrocardiography, ecocardiography and MRI.
  • Control
    Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI.
    Intervention: Diagnostic Test: Electrocardiography, ecocardiography and MRI.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2020)		 123
Original Estimated Enrollment
 (submitted: July 10, 2018)		 190
Actual Study Completion Date August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age: 20-80 years
  • weight: 50-120 kg
  • persistent, permanent or paroxysmal atrial fibrillation
  • clinically stable patients: outside of an acute cardiac event with constant chronic medication
  • optimum echographic window

Exclusion Criteria:

  • patients with: rheumatic mitral disease; acute myocardial-pericarditis; chronic rheumatism, under chronic or immunomodulatory treatment; infectious-inflammatory process of any cause
  • patients undergoing oncology treatment
  • patients under medication in another study
  • patients undergoing immunosuppressive therapy
  • contraindication for magnetic resonance imaging (MRI)
  • patients with valvular prosthesis, pacemaker of any type, metallic elements in the body (including metal particles accidentally in the body or as a result of exercising certain professions); pregnant patients; patients with known poly-allergy; patients with altered renal function (creatinine clearance <40 mL/min determined by the Cockcroft-Gault formula).
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT03584126
Other Study ID Numbers 20117/04.10.2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party County Clinical Emergency Hospital Cluj-Napoca
Original Responsible Party Same as current
Current Study Sponsor County Clinical Emergency Hospital Cluj-Napoca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Zoltán Bálint, PhD County Clinical Emergency Hospital Cluj-Napoca
PRS Account County Clinical Emergency Hospital Cluj-Napoca
Verification Date September 2020